Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/35

 . That was obviously arbitrary and capricious in State Farm. And so too here. The fact that mifepristone might be safe when used with the 2000 Approval’s REMS (a question studied by FDA) says nothing about whether FDA can eliminate those REMS (a question not studied by FDA).

True, FDA studied the safety consequences of eliminating one or two of the 2000 Approval’s REMS in isolation. But it relied on zero studies that evaluated the safety-and-effectiveness consequences of the 2016 Major REMS Changes as a whole. This deficiency shows that FDA failed to consider “an important aspect of the problem” when it made the 2016 Major REMS Changes. Michigan v. EPA, 576 U.S. at 752 (quotation omitted).

Second, the 2016 Major REMS Changes eliminated the requirement that non-fatal adverse events must be reported to FDA. After eliminating that adverse-event reporting requirement, FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is “safe.” See, e.g., FDA Add. 861–76 (explaining that FDA’s FAERS database, which collates data on adverse events, indicated that the 2016 Major REMS Changes hadn’t raised “any new safety concerns”). This ostrich’s-head-in-the-sand approach is deeply troubling—especially on a record that, according to applicants’ own documents, necessitates a REMS program, a “Patient Agreement Form,” and a “Black Box” warning. See. And it suggests FDA’s actions are well “outside the zone of reasonableness.” Prometheus, 141 S. Ct. at 1160. It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.

These actions make it unlikely that plaintiffs’ arbitrary-and-capricious challenges will fail on the merits, at least as far as they challenge FDA’s decisions including and following the 2016 Major REMS Changes.